Quality of drugs imported, manufactured in country regulated under Drugs & Cosmetics Act, 1940
New Delhi, : The quality of drugs imported, manufactured and sold in the country is regulated under the provisions of Drugs and Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945 made there under.
Official sources here said there is no definition of ‘generic drugs’ in the said Act & Rules. However, generic medicines are generally those which contain same amount of same active ingredient(s) in same dosage form, and are intended to be administered by the same route of administration as that of branded medicines.
The medicines, whether branded, generic or branded-generic, imported or manufactured for sale, distribution in the country, are required to comply with the same standards as specified in the Second Schedule to the Drugs and Cosmetics Act, 1940.
These medicines are available easily in the country, especially in Delhi. Further, “Public Health & Hospitals” being a state subject, the primary responsibility of ensuring the sufficient supply of free medicines is that of respective state governments, they added.
Under the National Health Mission, the Centre supplements the efforts of state governments to strengthen their healthcare system including for provision of free essential medicines in public health facilities, based on proposals of the state governments.
Under the NHM, financial and technical support is provided to the states, UTs not only for provision of essential drugs (mostly all generic), free of cost, in public health facilities but also for strengthening/setting up robust systems of procurement, quality assurance mechanism, warehousing, prescription audit, grievance redressal, dissemination of Standard Treatment Guidelines, and IT backed supply chain management systems like Drugs and Vaccines Distribution Management Systems.
UNI.